CATEGORY: HEALTHY AGING & LONGEVITY
In the first large randomized trial to start statin treatment in adults over 70 with no history of heart disease, a daily atorvastatin tablet cut major cardiovascular events by 30%—6.0% of people on the statin had a heart attack, stroke, cardiovascular death or artery-opening procedure over nearly six years, compared with 8.3% on placebo—but it did not lengthen the time participants lived free of dementia and physical disability, according to results published in the New England Journal of Medicine.1 The trial, called STAREE, answers a question that guidelines had left open because earlier statin trials rarely enrolled people this old.
Nearly Ten Thousand Australians, a Coin Flip, and Six Years of Records
Researchers recruited 9,971 adults aged 70 and older through general practices across Australia—average age 74.7, 52% women—none of whom had known cardiovascular disease, diabetes or dementia. Each was assigned by chance to atorvastatin, a widely used statin (a drug that lowers cholesterol by reducing how much the liver makes), or to an identical placebo, with the tablets mailed to participants’ homes. Because chance, not choice, decided who got the drug, the two groups started out alike in everything else, and any difference at the end can be credited to the statin itself. The dose began at 20 mg and rose to 40 mg after a month if tolerated. Over a median of 5.9 years the team tracked two co-primary outcomes: major cardiovascular events (cardiovascular death, nonfatal heart attack, stroke, or a procedure to open a blocked coronary artery), and disability-free survival, meaning how long each person lived without dying, developing dementia, or becoming persistently physically disabled. The trial was funded by Australia’s National Health and Medical Research Council and the Heart Foundation of Australia.
Two Fewer Events per Hundred People, and a Second Yardstick That Did Not Move
Major cardiovascular events occurred in 297 people taking atorvastatin and 412 taking placebo—6.0% versus 8.3%, a hazard ratio of 0.70 (95% confidence interval 0.61 to 0.82), which translates to a 30% lower risk. In absolute terms that is a little over two fewer events for every hundred people treated over roughly six years. Picture a community hall filled with 100 healthy people in their seventies: over six years, about eight of them would ordinarily have a major cardiovascular event; with the statin, about six would. LDL cholesterol, the kind that builds up in artery walls, fell by 48 mg/dL in the statin group against 16 mg/dL on placebo. The second yardstick told a different story. Death, dementia or persistent disability occurred in 637 people on atorvastatin and 676 on placebo—12.8% versus 13.6%, a hazard ratio of 0.94 (0.84 to 1.05)—a difference small enough to be due to chance.
The Expectation the Trial Did Not Meet
STAREE was built around the idea that preventing heart attacks and strokes in later life would translate into more years of independent living, which is why disability-free survival was made a co-primary outcome rather than an afterthought. The investigators wrote that the lower incidence of major, nonfatal cardiovascular events with atorvastatin “did not result in a corresponding improvement in disability-free survival.” One reason lies in the arithmetic of old age: about 80% of deaths in the trial were from non-cardiovascular causes, and dementia and frailty have many drivers that a cholesterol drug does not touch. Lowering cholesterol closed off one path to disability while leaving the others open. Lead investigator Sophia Zoungas said the trial gives older people reassurance that an effective measure exists for lowering heart attack and stroke risk, while cautioning that the evidence had previously been insufficient to recommend statins for this age group.
More Muscle, Liver and Blood Sugar Complaints, but No Rise in Serious Harm
Side effects followed the familiar statin pattern. Muscle and joint complaints were reported by 32.0% of the statin group and 29.4% of the placebo group; liver and gallbladder problems by 3.3% versus 0.9%; and new diabetes-related events by 4.0% versus 2.7%. Serious adverse events were uncommon and identical in both arms at 2.7%. About 7.2% of participants stopped the trial because of side effects. For a reader, the picture is a modest excess of mostly minor complaints set against a real reduction in heart attacks and strokes, with no gain in the outcome many older people say they care about most—staying independent.
Filling the Gap the Guidelines Had Left Open
The finding fits what earlier evidence hinted at while supplying the piece that was missing. A 2019 pooled analysis of 28 randomized trials involving 186,854 people found that statins reduced major vascular events in every age group, but only 8% of those participants were over 75, and the authors noted there was less direct evidence of benefit among people that age who had no established heart disease.2 STAREE is the trial designed to fill that gap, and on cardiovascular events it lands the same way as the pooled data. Where it adds something new is the null result on disability-free survival, which shifts the question for an older adult from “does a statin work?” to “which outcome matters to me?”
Key Takeaways
- In healthy adults over 70, atorvastatin lowered the risk of major cardiovascular events by 30%—6.0% versus 8.3% over nearly six years, or about two fewer events per hundred people treated.
- The statin did not extend the time people lived free of death, dementia or persistent disability: 12.8% versus 13.6%, a difference consistent with chance.
- Because participants were assigned by chance, the trial can credit the statin itself for the drop in heart attacks and strokes.
- Muscle, liver and blood sugar complaints were somewhat more common on the statin, while serious adverse events were equally rare in both groups.
References
- Zoungas S, et al. Atorvastatin, cardiovascular events, and disability-free survival in older adults. New England Journal of Medicine. 2026; published online August 29, 2026:NEJMoa2607314. link
- Cholesterol Treatment Trialists’ Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. The Lancet. 2019;393(10170):407–415. link